Background and history

The initiative to begin the harmonisation process came in 1983 when the first International Technical Consultation on Veterinary Drug Registration (ITCVDR) was held. Since then a series of government and industry initiatives have been developed, culminating in the formation of the VICH.

• The Codex Alimentarius formed a Committee on Residues of Veterinary Drugs in Foods in 1985.
• Standard requirements for veterinary product registration were adopted in Europe in 1981.
• The US FDA and the European Commission have held regular bilateral meetings for the last decade to discuss common areas of interest. This has involved mutual exchange of guidelines for consultation.
• The first International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was held in Brussels in November 1991. The meeting brought together regulators and industry representatives from the US, the EU and Japan to address quality, safety and efficacy requirements in the three regions.
• Meetings on harmonisation of veterinary biologicals were held in Ploufragan, France, in January 1992, in Arlington, US, in 1994 and in Singapore in 1995.
• In January 1993 the GHOST (Global harmonisation of standards) discussion document was published by FEDESA. It set out a programme for the international harmonisation of registration requirements for veterinary pharmaceuticals and biologicals.
• Following discussions at ITCVDR and Office International des Epizooties (OIE) conferences, the OIE set up an ad hoc group on harmonisation of veterinary medicinal products in 1994.

The birth and scope of VICH

Preparatory work for the establishment of VICH was carried out by this OIE ad hoc group. Two meetings were held in 1994 and in 1995 at which the scope of veterinary harmonisation was discussed and the membership and objectives of the VICH proposed. On the subject of food safety standards, it was decided that the VICH should complement the work of Codex and JECFA. Issues related to GLP and GMP which are already the subject of mutual agreements will not normally come within the remit of the VICH. Issues related to biologicals were considered appropriate to fall within the scope of VICH. Fundamental to the selection of priority topics for consideration by the VICH was the discussion document prepared by COMISA for the Steering Committee. This report:

• Assesses those ICH guidelines which could be adapted to the VICH programme;
• Defines in detail areas of non-harmonisation between the EU, the US and Japan and provides a series of “concept papers” on key topics; and
• Puts forward preliminary suggestions for priority topics.

With all the ground-breaking work completed, the Steering Committee of the VICH held its first meeting in April 1996, at which the membership and the working procedures were agreed and a work programme established.

The Objectives of VICH

The objectives of the VICH are along the same lines as those of the ICH. The VICH will:

• Establish and implement harmonized regulatory requirements for veterinary medicinal products in the VICH Regions, which meet high quality, safety and efficacy standards and minimize the use of test animals and costs of product development.
• Provide a basis for wider international harmonization of registration requirements.
• Monitor and maintain existing VICH guidelines, taking particular note of the ICH [1] work program and, where necessary, update these VICH Guidelines.
• Ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following the implementation of VICH guidelines.
• By means of a constructive dialogue between regulatory authorities and industry provide technical guidance enabling response to significant emerging global issues and science that impact on regulatory requirements within the VICH regions.

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[1] ICH – International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use

The parties to VICH (number of seats in Steering Committee)